Background
Malaria remains one of the leading causes of childhood mortality. In 2023, there were 263 million cases and 597,000 deaths globally, with 94% of cases and 95% of deaths in the WHO African Region. Children under 5 accounted for 76% of malaria deaths—over 1,000 young lives lost daily. Children can experience multiple episodes yearly, with Plasmodium vivax adding relapse risks in Southeast Asia and South America. Each episode disrupts education and imposes economic strain, while repeated infections can impair physical and cognitive development.
Prioritization is a necessary first step to enable a targeted approach to research and development. Developing a prioritized drug portfolio of the most needed formulations for children is essential to streamline researchers’ and supplier’s efforts and resources around specific dosage forms and formulations that address most urgent needs for children. This is particularly important given that the market for paediatric medicines is often small and/or fragmented, resulting in limited volumes with potential market failures.
The prioritization process is typically informed by a full understanding of the burden of the disease, a review of the need for specific therapeutics as recommended by WHO guidelines (or alternative normative standards), a detailed overview of the drug landscape and pipeline as well as a thorough review of current market, procurement, access and implementation challenges. This background assessment is undertaken in preparation for PADO meetings.
In June 2025, the World Health Organization (WHO) convened the first-ever PADO process for malaria.
The objectives of PADO for malaria were:
- To review WHO-endorsed options for the treatment and prevention of malaria and discuss whether age-appropriate formulations are missing that need to be given priority for development (PADO priority list, 3-5 years).
- To review candidates for the treatment of prevention of malaria that are being investigated clinically, including new chemical entities as well as combinations of medicines approved for use in children as individual medicines but not yet evaluated as a combination by WHO, and identify promising candidates that should be prioritized for investigation and development for children (PADO watch list, 5-10 years).
- To develop a clear research agenda to support and enable future optimization work, with the goal of ensuring the unique needs of children are effectively addressed.
The group was reminded that the PADO process is not a guidelines process and as such is not intended to endorse the use of products that have not been fully assessed by a WHO guidelines development group. However, prioritization provides a clear signal that specific formulations and products are of interest in the short, medium or long term and that stakeholders should work together towards completing investigation and development of age-appropriate formulations.
WHO is now seeking feedback on the proposed PADO lists of short term and long priorities, as well as key research questions to accelerate research and development of the priorities identified. Industry experts, product developers, the scientific community, implementers, clinicians, and health programme personnel currently involved in the management of malaria are all invited to submit their feedback via the table provided below. Together we can work on making an impact in developing better formulations for children with malaria.
Please, submit your feedback to: Gap-f@who.int